PURCHASE SPECIFICATIONS FOR NUAIRE PHARMAGARD™ NU-PR797 POSITIVE PRESSURE RECIRCULATING STERILE ISOLATOR The intent herein is to provide a concise statement of requirements for a quality Sterile Products Compounding Isolator, which may be used to augment your purchase request/order. The NU-PR797 meets the barrier isolator requirements of the USP 797, Pharmaceutical Compounding Sterile Preparations. NuAire sales representatives will be pleased to explain the importance of the performance and control affected by each of the following requirements. The NuAire NU-PR797 meets all of the requirements in the following SPECIFICATION. 1. Dimensions Inches (mm) Overall Dimensions Width (W) Depth (D) Height (H) (minimum w/optional adjustable basestand) *2. NU-PR797-400 50 (1270) 32-1/2 (826) 51-1/2 (1308) 78 (1981) NU-PR797-600 74 (1880) 32-1/2 (826) 51-1/2 (1308) 78 (1981) Workzone Interior Dimensions Width (W) Depth (D) (center of gloveport) Height (H) 35-1/4 (895) 23-1/4 (591) 27-3/8 (695) 59-1/4 (1505) 23-1/4 (591) 27-3/8 (695) Interchange Interior Dimensions Width (W) Depth (D) (at worksurface) Height (H) 14-1/8 (359) 24 (610) 27-3/8 (695) 14-1/8 (359 24 (610) 27-3/8 (695) Cabinet shall provide performance as specified. a. Cabinet shall maintain a positive pressure with in workzone and slightly less positive pressure in the interchange to assure preparation and transfer sterility. b. Cabinet shall provide better than ISO Class 5 (Federal Standard 209E Class 100) within workzone and interchange. c. Supply HEPA filter shall be the full length of the cabinet workzone providing better than ISO Class 5 Laminar Downflow designed to eliminate cross contamination on the worksurface. d. Supply HEPA filter shall be protected by perforated metal diffusers covering the entire top of both workzone and interchange. Process #9-1117 Pgs 1-6 REV 8 12/08 *3. The cabinet shall be ergonomically designed for maximum user comfort and process efficiency. *4. Cabinet shall have a centrally located instrument panel within the control center that is easily serviced with quick disconnects. Cabinet shall have the capability of incorporating a user adjustable base stand as an option. Cabinet shall have a hinged window slanted 10° from vertical for optimal work with glove ports. The hinged window shall allow full access to entire workzone and interchange. Cabinet shall have (2) independent worktrays for workzone and interchange being removable with coved corners for easy cleaning. Cabinet shall have large exterior hinged transfer door 9-1/4” x 18” (235 x 457mm) minimum for efficient product movement in and out of the transfer chamber. Cabinet shall have large interior sliding door 8-1/2” x 18-1/2” (216 x 470mm) minimum for efficient product movement in and out of the workzone. The cabinet shall have all filter positive pressure plenums surrounded by a vacuum relative to the room. 5. Electrical power shall be supplied with a 12-foot (2.5m), 3-wire cord with hospital grade plug. Electrical supply should be 115VAC, 60Hz protected with thermal circuit breaker from distribution panel. *6. The cabinet shall have two internal electrical circuits; one for blower/lights and one for the hospital grade duplex outlet. Each circuit shall be protected with a fuse located in the Control Center. 7. The cabinet shall be listed by Underwriters Laboratories to meet the requirements of both the U.S. and Canada for electrical/mechanical integrity. 8. Total cabinet airflow shall be controlled via a solid-state motor voltage regulator with adjustment available on the Control Center. *9. Balancing of cabinet positive pressure shall be accomplished with integrated prefilter/HEPA filter assembly. 10. The cabinet shall be easily transportable through a standard 36 inch (914mm) wide door without disassembly. 11. Fluorescent lighting shall be externally mounted and provide 40 (430) to 80 (860) foot-candles (LUX) on work surface. The ballast is to be electronic containing thermal protection with automatic reset. 12. Cabinet shall have two minihelic gauges to display positive pressure of workzone and interchange area. 13. Cabinet shall come standard with one hospital grade duplex with drip proof cover on back wall. *14. Cabinet shall be easily bench mounted or freestanding console model with the addition of the optional bench mount support or various basestand options. Process #9-1117 REV 8 12/08 2 15. Cabinet workzone shall be all 16 GA. stainless steel and reinforced with stainless steel “U” channels to minimize vibration. 16. Cabinet shall have a large removable workzone worktray with integral hinged support rods to be raised and held up for cleaning. *17. Cabinet shall have a permanent positive pressure plenum with quick release supply filter removal. *18. Cabinet shall be capable of front/top filter removal without disassembly of the control panel and hinged window hardware. 19. Cabinet shall have a three-position IV bar with 6 hooks. 20. The following optional equipment shall be available to support installation and user requirements: Hospital Grade Ground Fault Interrupter for Electrical System Additional Service Valves for Gas, Air, Vacuum Additional Hospital Grade Duplex Bench Mount Support Telescoping Support Stand Storage Pullout Trays Pull Out Shelf Cord Pass-Through Adjustable Automatic Base Support Stand with Castors Adjustable Automatic Base Support Stand with Leg Levelers Waste/Sharps (Sm) Disposable System for Non-Hazardous Drugs Sharps/Sharps (Lg) Disposable System for Non-Hazardous Drugs Pharmagard™ Digital Monitor Custom Options Available *Having all of these features is unique ONLY to NuAire cabinets. Process #9-1117 REV 8 12/08 3 Pharmagard™ Positive Pressure Recirculating Sterile Isolator Models NU-PR797-400/600 Catalog Number NU-PR797-400 NU-PR797-600 Nominal 4 foot (1.2m) Nominal 6 foot (1.8m) Catalog Number Performance Specifications 1. Product Protection Style of Isolator Isolator Construction Interchange Chamber Diffuser for Air Supply (Metal) HEPA Filter Seal Type: Supply Filter-99.99% Eff. on 0.3 microns Intake Filter-99.99% Eff. on 0.3 microns Standard Services: Hospital Grade Duplex Outlet Optional Services: Service Valves 3/8" NPT Isolator Size Inches (mm): Height Height (Minimum w/opt. Adjustable Base Stand) Width Depth (with Control Center) Work Zone Inches (mm): Width Height Depth (Center of Glove Port) Interchange Inches (mm) Width Depth (at Work Surface) Height Hinged Viewing Window (Polycarbonate) Heat Rejected, BTU, Per Hour Electrical: Volts, AC 60 Hz Amps: Blower/Lights Amps: Hospital Grade Duplex Amps: Total 12 ft. Hospital Grade Power Cord (one) *Crated Shipping Weight: *Net Weight: Net Optional Adjustable Automatic Base Stand Wt: Net Optional Telescoping Base Stand Wt: Net Optional Bench Mount Wt: ISO Class 5 (Laminar Flow) Bench top/console Isolator Welded stainless steel 16GA, Type 304 pressure tight design ISO Class 5 With Internal/External Sealed Doors Non-flammable ISO Class 5 (Laminar Flow) Bench top/console Isolator Welded stainless steel 16GA, Type 304 pressure tight design ISO Class 5 With Internal/External Sealed Doors Non-flammable Neoprene, Springloaded Under Negative Pressure Neoprene, Springloaded Under Negative Pressure One, Backwall One, Backwall Up to 3 Up to 3 51 1/2 (1308) 78 (1981) 50 (1270) 32 1/2 (826) 51 1/2 (1308) 78 (1981) 74 (1880) 32 1/2 (826) 35 1/4 (895) 27 3/8 (695) 23 1/4 (591) 59 1/4 (1505) 27 3/8 (695) 23 1/4 (591) 14 1/8 (359) 24 (610) 27 3/8 (695) Fully closed to fully open 539 UL/UL-C Listed 115 3 3 6 14 GA - 3 Wire, 15A 475 lbs./220 kg. 425 lbs./193 kg. 150 lbs./68 kg. 60 lbs./27 kg. 20 lbs./19 kg. 14 1/8 (359) 24 (610) 27 3/8 (695) Fully closed to fully open 880 UL/UL-C Listed 115 5 3 8 14 GA - 3 Wire, 15A 625 lbs./284 kg. 575 lbs./261 kg. 160 lbs./73 kg. 70 lbs./32 kg. 20 lbs./19 kg. * For total weight, must select and add (1) of (3) base options. Process #9-1117 REV 8 12/08 4 Process #9-1117 REV 8 12/08 5 Process #9-1117 REV 8 12/08 6